Needle capture safety interlock for catheter

ABSTRACT

A catheter assembly including a flexible catheter, a needle having a sharp distal tip, the needle disposed in the flexible catheter and moving from a first position that exposes the needle to a second position, an outer member that is configured to engage and disengage a catheter hub, an inner member disposed in the outer member, and a needle shield for shielding at least a distal end of the needle when the needle is in the second position and the needle being disposed through the needle shield in the first position.

RELATED APPLICATIONS

This application claims the benefit of, and for the United States, is acontinuation-in-part of, International Patent Application No.PCT/US2015/026534, filed Apr. 17, 2015, International Patent ApplicationNo. PCT/US2015/026536, filed Apr. 17, 2015, and International PatentApplication No. PCT/US2015/026542, filed Apr. 17, 2015, all of which arehereby incorporated by reference in their entirety.

FIELD

Various exemplary embodiments of the invention relate to catheters.

BACKGROUND

Catheter assemblies are used to place a catheter properly into thevascular system of a patient. Once in place, catheters such asintravenous catheters may be used to infuse fluids including normalsaline, medicinal compounds, and/or nutritional compositions into apatient in need of such treatment. Catheters additionally enable theremoval of fluids from the circulatory system and monitoring ofconditions within the vascular system of the patient.

SUMMARY OF THE INVENTION

It is an aspect of the present invention to provide a catheter assemblyin which a flexible needle shield advantageously provides improvedneedle protection in a simple design and reduces needle drag when theneedle is withdrawn. The needle shield advantageously retains andreduces movement of an inner member during operation. The inner memberis also retained in an outer member to advantageously prevent the twocomponents from separating after use. These and other advantages aredescribed in the embodiments below.

The foregoing and/or other aspects of the present invention can beachieved by providing a catheter assembly comprising a flexiblecatheter, a needle having a sharp distal tip, the needle disposed in theflexible catheter and moving from a first position that exposes theneedle to a second position, an outer member that is configured toengage and disengage a catheter hub, an inner member movably disposed inthe outer member, and a needle shield for shielding at least a distalend of the needle when the needle is in the second position and theneedle passing through the needle shield in the first position.

The foregoing and/or other aspects of the present invention can also beachieved by providing a method of operating a catheter assemblycomprising disposing a needle having a sharp distal tip in a flexiblecatheter and in a first position, retracting the needle from a catheterhub and through the flexible catheter and through a needle shield,shielding at least the distal tip of the needle by the needle shield andin an inner member via a second position, and moving the needle shieldand an outer member when retracting the needle to the second position.

Additional and/or other aspects and advantages of the present inventionwill be set forth in the description that follows, or will be apparentfrom the description, or may be learned by practice of the invention.

BRIEF DESCRIPTION OF THE DRAWINGS

The above aspects and features of the present invention will be moreapparent from the description for the exemplary embodiments of thepresent invention taken with reference to the accompanying drawings, inwhich:

FIG. 1 is a perspective view of an exemplary catheter with a needlecover attached;

FIG. 2 is a perspective view of the catheter of FIG. 1 with the needlecover removed;

FIG. 3 is a perspective view of an exemplary side-port catheter andneedle cover;

FIG. 4 is a sectional, side view of the catheter of FIG. 1;

FIG. 5 is a sectional, side view of the catheter of FIG. 3;

FIG. 6 is an exploded, perspective view of an exemplary needle, needleshield, and needle hub;

FIGS. 7A-D are perspective views of the outer sleeve of the exemplaryneedle shield of FIG. 6;

FIG. 7E is a top view of the outer sleeve of FIG. 6;

FIG. 7F is a right side of the outer sleeve of FIG. 6;

FIG. 7G is a bottom view of the outer sleeve of FIG. 6;

FIG. 7H is a front view of the outer sleeve of FIG. 6;

FIG. 7I is a rear view of the outer sleeve of FIG. 6;

FIG. 7J is a left side view of the outer sleeve of FIG. 6;

FIG. 8A is a perspective view of the needle shield connected to thecatheter hub;

FIG. 8B is a top view of the needle shield connected to the catheterhub;

FIGS. 9A-D are perspective views of the inner sleeve of the exemplaryneedle shield of FIG. 6;

FIG. 9E is a top view of the inner sleeve of FIG. 6;

FIG. 9F is a right side view of the inner sleeve of FIG. 6;

FIG. 9G is a bottom view of the inner sleeve of FIG. 6;

FIG. 9H is a front view of the inner sleeve of FIG. 6;

FIG. 9I is a rear view of the inner sleeve of FIG. 6;

FIGS. 10A-D are perspective views of the clip of the exemplary needleshield of FIG. 6;

FIG. 10E is a right side view of the clip of FIG. 6;

FIG. 10F is a front view of the clip of FIG. 6;

FIG. 10G is a left side view of the clip of FIG. 6;

FIG. 10H is a top view of the clip of FIG. 6;

FIG. 10I is a bottom view of the clip of FIG. 6;

FIG. 11 is a sectional, side view of the exemplary needle shield of FIG.6;

FIG. 12 is a sectional, top view of the exemplary needle shield of FIG.6;

FIG. 13 is a sectional, side view of another exemplary needle shieldconnected to a catheter hub with an introducer needle extending into thecatheter hub;

FIG. 14 is a sectional, side view of the exemplary needle shield of FIG.13 with the needle withdrawn into the needle shield;

FIG. 15 is a sectional, side view of the exemplary needle shield of FIG.13 with the inner sleeve withdrawn from the catheter hub and into theouter sleeve;

FIG. 16 is a sectional, side view of the exemplary needle shield of FIG.13 with the needle shield being removed from the catheter hub;

FIGS. 17A-C illustrates another exemplary embodiment of a needle shieldbeing connected, and then removed from, a catheter hub;

FIG. 18 illustrates another exemplary embodiment of a needle shieldconnected to a catheter hub;

FIG. 19 illustrates another exemplary embodiment of a needle shieldconnected to a catheter hub;

FIG. 20 illustrates another exemplary embodiment of a needle shieldremoved from a catheter hub;

FIG. 21A illustrates another exemplary embodiment of a needle shieldconnected to a catheter hub;

FIG. 21B is an enlarged view of FIG. 21A showing the engagement of theouter sleeve and inner sleeve with the catheter hub;

FIG. 22A is a sectional, side view of another exemplary embodiment of aneedle shield connected to a catheter hub;

FIG. 22B is the needle shield and catheter hub of FIG. 22A with theneedle drawn into the outer sleeve;

FIG. 22C is the needle shield of FIG. 22A separated from the catheterhub;

FIG. 23A is a sectional, side view of another exemplary embodiment of aneedle shield connected to a catheter hub;

FIG. 23B is the needle shield of FIG. 23A with the inner sleevewithdrawn from the catheter hub and a biasing member disengaging thecatch;

FIGS. 24A-D are perspective views of an exemplary inner sleeve with anintegral clip;

FIG. 24E is a top view of the inner sleeve with an integral clip shownin FIG. 24A;

FIG. 24F is a right side view of the inner sleeve with an integral clipshown in FIG. 24A;

FIG. 24G is a front view of the inner sleeve with an integral clip shownin FIG. 24A;

FIG. 24H is a rear view of the inner sleeve with an integral clip shownin FIG. 24A;

FIG. 24I is a bottom view of the inner sleeve with an integral clipshown in FIG. 24A;

FIG. 25A is an exploded, perspective view of an exemplary catheterhaving a needle shield and a spring-return blood control actuator andseptum;

FIG. 25 is a perspective view of the septum of FIG. 25A;

FIG. 26A is a sectional, side view of the catheter of FIG. 25A;

FIG. 26B is a sectional, side view of the catheter of FIG. 26A with theneedle removed;

FIG. 26C is a sectional, side view of the catheter of FIG. 26B with amale Luer connector inserted into the catheter hub;

FIG. 26D is a sectional, side view of the catheter of FIG. 26C with theLuer connector pushing the actuator through the septum;

FIG. 26E is a sectional, side view of the catheter of FIG. 26D with themale Luer connector being withdrawn from the catheter hub;

FIG. 26F is a sectional, side view of the catheter of FIG. 26E with themale Luer connector withdrawn from the catheter hub;

FIG. 27 illustrates a right side view of another exemplary embodiment ofan actuator;

FIG. 28A illustrates a cross sectional view of the actuator of FIG. 27in a catheter hub assembly;

FIG. 28B illustrates the cross sectional view of the catheter hubassembly of FIG. 28A when piercing a septum;

FIG. 28C illustrates a left perspective cross sectional view of thecatheter hub assembly of FIG. 28A when piercing a septum;

FIG. 29A illustrates a cross sectional view of another exemplaryembodiment of a catheter hub assembly;

FIG. 29B illustrates the cross sectional view of the catheter hubassembly of FIG. 29A when piercing a septum; and

FIG. 29C illustrates a left perspective cross sectional view of thecatheter hub assembly of FIG. 29A when piercing a septum.

FIG. 30 illustrates a right perspective cross sectional view of anotherembodiment of a catheter hub and a needle shield assembly;

FIG. 31 illustrates a cross sectional top view of the catheter hub andthe needle shield assembly of FIG. 30 in a first needle position withthe needle shield assembly engaged to the catheter hub;

FIG. 32 illustrates a side cross sectional view of the catheter hub andthe needle shield assembly of FIG. 30 in the first needle position withthe needle shield assembly engaged to the catheter hub;

FIG. 33 illustrates a right perspective cross sectional view of thecatheter hub and the needle shield assembly of FIG. 30 in a secondneedle position with the needle shield assembly engaged to the catheterhub;

FIG. 34 illustrates a cross sectional right perspective view of thecatheter hub and the needle shield assembly of FIG. 30 in the secondneedle position with the needle shield assembly disengaging the catheterhub; and

FIG. 35 illustrates a cross sectional top view of the catheter hub andthe needle shield assembly of FIG. 30 in the second needle position withthe needle shield assembly disengaged from the catheter hub.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS

A catheter 10, as illustrated in FIGS. 1-6, includes a hollow metalintroducer needle 12, a catheter hub 14, a needle hub 16, a needle cover18, and a needle shield 20. The needle cover 18 initially covers theneedle 12 and at least a portion of the catheter hub 14. The needlecover 18 can connect to the catheter hub 14 or to the needle hub 16. Theneedle 12 has a sharpened distal end and initially extends through theneedle shield 20 and the catheter hub 14. A flexible catheter tube 22extends from the distal end of the catheter hub 14, with the introducerneedle 12 passing through the catheter tube 22. Initially, the needle 12is exposed (first position, for example) and is inserted into apatient's vein. The catheter tube 22 is pushed along the needle 12 andinto the vein following the needle 12. After the catheter tube 22 isinserted, the needle 12 is removed from the patient's vein and thecatheter hub 14. The needle shield 20 encloses the sharp distal tip ofthe needle 12 and provides protection from being stuck by the needle 12during and after the needle's retraction from the catheter hub 14. Theneedle shield 20 can be used with a variety of different catheters,including standard catheter hubs 14 as shown in FIGS. 2 and 4 andside-port catheter hubs 24 as shown in FIGS. 3 and 5.

In accordance with various exemplary embodiments, the needle shield 20includes an outer member 26, an inner member 28, and a resilient clip30. The outer and inner members 26, 28 are preferably in the form ofsleeves. The outer sleeve 26 connects to the catheter hub 14 andsurrounds the inner sleeve 28, and the clip 30. The inner sleeve 28 ispositioned in the outer sleeve 26 and is moveable in the axial directionrelative to the outer sleeve 26. The clip 30 is connected to, andaxially moveable with, the inner sleeve 28. The outer sleeve 26, innersleeve 28, and clip 30 may be formed from a metal, elastomer, polymer,or composite material. In various exemplary embodiments, the outersleeve 26 and the inner sleeve 28 are molded from a polymer material andthe clip 30 is formed from a thin piece of resilient metal, such asstainless steel. The clip in the various embodiments disclosed can actas an exemplary needle protection member. The features of the exemplaryembodiments of FIGS. 1-6 may be combined with features of the otherexemplary embodiments disclosed herein as appropriate.

In accordance with the exemplary embodiments depicted in FIGS. 7A-7J,the outer sleeve 26 includes an outer surface 32, an inner surface 34, aproximal opening 36, and a distal opening 38. The outer surface 32 hasan octagonal configuration with eight planar sides, although othercurvilinear and/or rectilinear shapes may be used. The inner surface 34has a planar top wall and a planar bottom wall connected by a pair ofcurved sides. The inner surface 34 defines a cavity for receiving theinner sleeve 28. The introducer needle 12 initially extends through theproximal and distal openings. A slot 40 extends through a wall of theouter sleeve 26. The size, shape, and configuration of the outer sleevemay vary depending on space requirements and the type of catheter hub14.

A catch 42 extends from the outer surface to engage or interlock with aprotrusion 44 on the catheter hub 14 as best shown in FIGS. 8A-8B. Thisengagement takes place prior to the needle 12 being enclosed by the clip30. In various exemplary embodiments the catch 42 may be configured toengage any type of feature on the catheter hub 14, including a groove,slot, or hole. Modification of the catch 42 may be dependent on theconfiguration of the catheter hub 14. In the exemplary embodiment, thecatheter hub protrusion 44 is a Luer receiving thread, for example aLUER-LOK® style of thread.

The catch 42 has a front edge, a back edge, and a pair of side edges. Anopening or depression is formed between the front edge and the back edgeto receive the catheter hub protrusion 44. The opening allows the catch42 to be formed with a clearance approximately equal to, or slightlygreater than the height of the projection 44, allowing the catch 42 toengage the front, back, and/or sides of the Luer thread projection 44while minimizing the amount of material and space needed. In variousexemplary embodiments, the opening may be omitted. The catch 42 resistspremature release of the needle shield 20 from the catheter hub 14. Thefeatures of the exemplary embodiments of FIGS. 7A-8B may be combinedwith features of the other exemplary embodiments disclosed herein asappropriate.

In accordance with the exemplary embodiments depicted in FIGS. 9A-9I,the inner sleeve 28 includes a base 46, a distal side 48, and a proximalside 50. A resilient leg 52 and a foot 54 extend from an outer surfaceof the base 46. The resilient leg 52 and the foot 54 engage the slot 40in the outer sleeve 26. One or more clip retainers 56 extend from aninner surface of the base 46. The dip 30 is positioned between the clipretainers 56 and the proximal side 50. An opposing member 58 extendsfrom the distal side 48 in the distal direction. The opposing member 58is configured to be inserted into the catheter hub 14 when the needle 12is in the exposed position (first position, for example). In theexemplary embodiment shown in FIGS. 9A-9I the opposing member is atubular member. The proximal side 50, distal side 48, and opposingmember 58 each has an opening for receiving the introducer needle 12.The size, shape, and configuration of the inner sleeve 28 may varydepending on space requirements and the type of catheter hub 14, andouter sleeve 26.

In an alternate embodiment of the inner sleeve 18, a bridge member (notshown) can be incorporated to improve the strength of the inner sleeve18. Specifically, the top surface of the distal side 48 and the topsurface of the proximal side 50 can be connected by a solid memberhaving a similar length of the base 46. The inner sleeve 18 can bemanufactured by injection molding, for example.

In another alternate embodiment, the foot 54 of the base 46 can beremoved and the base 46 can be a solid member. According to thisconfiguration, the inner sleeve 28 deforms in the outer sleeve 26 toachieve appropriate retention. The inner and outer sleeves 28, 26 areappropriately sized so that the inner sleeve 28 can also axially moveinside and relative to the outer sleeve 26 upon applying a predeterminedforce. If a force less than the predetermined force is applied, theinner sleeve 28 does not move relative to the outer sleeve 26. Such aconfiguration improves moldability and manufacturability of the innersleeve 28 and outer sleeve 26. The features of the exemplary embodimentsof FIGS. 9A-9I may be combined with features of the other exemplaryembodiments disclosed herein as appropriate.

In accordance with the exemplary embodiments depicted in FIGS. 10A-10I,the resilient dip 30 includes a base 60 having an opening for receivingthe needle 12, a first arm 62, and a second arm 64 extending from thebase 60. The first arm 62 extends further in the axial direction thanthe second arm 64. The first arm 62 has a first hook 66 and the secondarm 64 has a second hook 68. A first tab 70 is formed in the first arm62 and a second tab 72 is formed in the second arm 64. The features ofthe exemplary embodiments of FIGS. 10A-10I may be combined with featuresof the other exemplary embodiments disclosed herein as appropriate.

FIGS. 11 and 12 depict the exemplary embodiment of the needle shield 20in an assembled condition. FIG. 11 shows the leg 52 and foot 54 of theinner sleeve 28 positioned in the slot 40 of the outer sleeve 26. Thefoot 54 engages the slot 40 to resist axial movement of the inner sleeve28 with respect to the outer sleeve 26 past the point where the foot 54engages an edge of the slot 40. The leg 52 and foot 54 can also beformed on the outer sleeve 26 with the slot 40 formed on the innersleeve 28. FIG. 12 shows the first and second clip tabs 70, 72 engaginga first shoulder 74 and a second shoulder 76 on the outer sleeve 26. Thetabs 70, 72 help prevent the clip 30 and the inner sleeve 28 fromunintentionally sliding into the outer sleeve 26, for example duringshipping. In the initial position, the introducer needle 12 biases thefirst and second arms 62, 64 into an open position so that the tabs 70,72 engage the outer sleeve 26.

FIGS. 13-16 depict another example embodiment of the needle shield 78and depict an example of the needle shield 20 in operation. Initially,the introducer needle 12 passes through the outer sleeve 80, the innersleeve 82, and the clip 84. The introducer needle 12 biases the clip 84into an open position, so that the first and second hooks are restingalong the needle shaft 12. In the assembled position, the catch 86engages the Luer thread 44 on the outer surface of the catheter hub 14and the opposing member extends into the proximal opening of thecatheter hub 14. In order to remove the catch 86 from the catheter hub14, the outer sleeve 80 of the shield 78 must be raised so that thecatch 86 can slide over the Luer thread 44. Raising the needle shield 78relative to the catheter hub 14, however, is initially prevented by theopposing member 88 extending into the catheter hub 14.

As the needle 12 is withdrawn from the catheter hub 14, the tip of theneedle 12 clears the first and second hooks causing the first and secondarms to close and the first and second hooks to surround the tip of theneedle 12. After the tip of the needle 12 passes the first and secondhooks and the first and second arms move into a closed orientation, thetab 85 disengages the outer sleeve 80 and the inner sleeve 82 may bemoved axially further into the outer sleeve 80. A second position canrefer to the closed position, whereas the first position can refer toany needle 12 position prior to entering the second position.

As the needle 12 is pulled further, the shaft of the needle slidesthrough the needle shield 78 until a deformation 90, for example a crimpor protrusion formed near the distal end of the needle 12 to increaseits diameter, engages the clip base as shown in FIG. 14. The opening inthe dip base is sized to allow passage of the needle shaft, but not thedeformation 90. Thus, when the tip of the needle 12 is in the closedposition of the clip 84, the deformation 90 is also enclosed by the clip84.

Further movement of the needle 12 including the deformation 90 resultsin the inner sleeve 82 being drawn further into the outer sleeve 80,removing the opposing member 88 from the catheter hub 14 as shown inFIG. 15. Specifically, the inner sleeve 82 moves relative to the outersleeve 80. When the opposing member 88 is withdrawn from the catheterhub 14, the needle shield 78 can be moved radially relative to thecatheter hub 14. The catch 86 can then be lifted from the Luer threadprotrusion 44 and the needle shield 78, needle 12, and needle hub 16 canbe separated from the catheter hub 14.

In the exemplary embodiment shown in FIGS. 11 and 12, after the needleshield 20 is removed, distal movement of the inner sleeve 28 relative tothe outer sleeve 26 in the axial direction can cause the foot 54 toengage the slot 40, resisting separation of the inner sleeve 28 and theouter sleeve 26 and possible exposure of the needle 12 tip. Theengagement of the needle deformation 90 and the dip base 60 prevents theneedle 12 from being withdrawn from the needle shield 20 in the proximaldirection. The features of the exemplary embodiments of FIGS. 11 and 12may be combined with features of the other exemplary embodimentsdisclosed herein as appropriate.

The needle shield 78 depicted in FIGS. 13-16 is similar to the needleshield 20 depicted in FIGS. 3-12. The outer sleeve 80 of the needleshield in FIGS. 13-16 includes one or more keyway grooves 92 extendingfrom a rounded surface. The keyway grooves 92 prevent rotation of theinner sleeve 82 relative to the outer sleeve 80. The inner sleeve 82includes a frusta-conical clip retainer 94 tapering from the proximalend to the distal end. The sides of the dip retainer 94 are configuredto abut the dip 84 when it is in the closed orientation.

In various exemplary embodiments, the clip retainer 94 has a surfacethat extends so that one of the hooks rests on the dip retainer 94 (notshown) throughout the removal of the needle 12. In this configuration,only a single arm moves from the open orientation to the closedorientation. The use of a single moving arm reduces friction on theneedle 12 and helps prevent binding during the needle's withdrawal fromthe catheter hub 14. In certain embodiments, the needle shield isconfigured to use a clip with only a single arm, although two arms arebeneficial in certain applications to balance the clip and resisttilting of the dip's base relative to the needle 12. The features of theexemplary embodiments of FIGS. 13-16 may be combined with features ofthe other exemplary embodiments disclosed herein as appropriate.

FIGS. 17A-17C depict another exemplary embodiment of the needle shield96 having an outer sleeve 98 and a metal clip 100 with a single arm,omitting the inner sleeve. The outer sleeve 98 has latch 102 acting asan opposing member. The latch 102 has a first arm extending from aninner surface of the outer sleeve 98 and a second arm hinged to thefirst arm, for example by a living hinge. The clip 100 includes a hookhaving a tab 104 extending in the distal direction to abut the latch102. The tab 104 and/or the inserted needle 12 may retain the latch 102in the closed configuration, prevent radial movement of the needleshield 96 with respect to the catheter hub 14 and therefore resistdisengagement of the catch from the Luer thread.

As the needle 12 is withdrawn into the needle shield 96, the clip 100moves into a closed position, disengaging the tab 104 from the latch 102and allowing the latch 102 to open as shown in FIG. 17B. After the latch102 is opened, the needle shield 96 can be disengaged from the catheterhub 14, as shown in FIG. 17C. In the closed position, the tab 104 may ormay not engage a bottom protrusion 106, preventing the needle 12 andmetal clip 100 from exiting the needle shield 96 in the distaldirection. The engagement of the needle deformation 90 and the clip baseprevents the needle 12 from being withdrawn from the needle shield 96 inthe proximal direction. The features of the exemplary embodiments ofFIGS. 17A-17C may be combined with features of the other exemplaryembodiments disclosed herein as appropriate.

FIG. 18 depicts another exemplary embodiment of the needle shield 108having an outer sleeve 110 and a metal clip 112 with a single arm,omitting the inner sleeve. The clip 112 includes a hook having a tab 114extending in the distal direction to act as the opposing member. The tab114 engages an inner surface of the catheter hub 14 to resist radialmovement of the needle shield 108 with respect to the catheter hub 14.As the needle 12 is withdrawn into the needle shield 108, the arm movesinto a closed position, disengaging the tab 114 from the catheter hub.This allows the needle shield 108 to disengage the catheter hub 14. Inthe closed position, the hook engages a bottom protrusion 116,preventing the needle 12 and clip 112 from exiting the needle shield 108in the distal direction. The engagement of the needle deformation 90 andthe clip base prevents the needle 12 from being withdrawn from theneedle shield 108 in the proximal direction. The features of theexemplary embodiments of FIG. 18 may be combined with features of theother exemplary embodiments disclosed herein as appropriate.

FIGS. 19 and 20 depict another exemplary embodiment of the needle shield118 having an outer sleeve 120 and a metal clip 122 with a first andsecond arm, omitting the inner sleeve. The first and second arms extendinto the catheter hub 14 to engage an inner surface of the catheter hub14 and act as the opposing member. As the needle 12 is withdrawn intothe needle shield, the arms move into a closed position. In certainembodiments, the closed position provides enough clearance for theneedle shield 118 to be removed from the catheter hub 14. In alternativeembodiments, the needle 12 engaging the dip 122 moves the clip 122inside of the outer sleeve 120 so that the first and second arms arecompletely withdrawn from the catheter hub 14 before the needle shield118 can be disengaged.

As shown in FIG. 20, a tab 124 may extend from one of the arms. The tab124 is angled so that it can be moved proximally into a slot 126 formedin the outer sleeve 120. The angle of the tab 124 engages a side of theslot 126 to resist distal movement of the clip 122 and needle 12 afterthe needle shield 118 has been removed from the catheter hub 14.Engagement of the needle deformation 90 with the clip 122 prevents theneedle 12 from being removed from the needle shield 118 in the proximaldirection. The features of the exemplary embodiments of FIGS. 19 and 20may be combined with features of the other exemplary embodimentsdisclosed herein as appropriate.

FIGS. 21A and 21B depict another exemplary embodiment of the needleshield 128 having an outer sleeve 130, an inner sleeve 132, and a dip134 with a first and second arm. The inner sleeve 132 extends into andabuts an inner surface of the catheter hub 14, acting as the opposingmember. As the needle 12 is withdrawn into the needle shield 128, thearms move into a closed position and the clip 134 pulls the inner sleeve132 out of the catheter hub 14 and into the outer sleeve 130.Disengagement of the inner sleeve 132 from the catheter hub 14 allowsthe needle shield 128 to be disengaged from the catheter hub 14. Thefeatures of the exemplary embodiments of FIGS. 21A and 21B may becombined with features of the other exemplary embodiments disclosedherein as appropriate.

FIGS. 22A-22C depict another exemplary embodiment of the needle shield148 having an outer sleeve 150, an inner sleeve 152, and a dip 154. Theclip 154 has a first arm 156 and a second arm 158. The first arm 156 ismoveable and includes a hook that captures the needle 12 when it isdrawn into the inner sleeve 152 the appropriate amount. A protrusion 160extends from the inner sleeve 152 to receive the second arm 158. Thesecond arm 158 therefore does not engage the needle during its movement.In this configuration, only the first arm 156 moves from the openorientation to the closed orientation. The use of a single moving armreduces friction on the needle 12 and helps prevent binding during theneedle's withdrawal from the catheter hub 14. The features of theexemplary embodiments of FIGS. 22A-22C may be combined with features ofthe other exemplary embodiments disclosed herein as appropriate.

FIGS. 23A-23B depict another exemplary embodiment of the needle shield162 having an outer sleeve 164, an inner sleeve 166, and a clip 168. Theouter sleeve 164 includes a biasing member 170 that extends into andabuts the catheter hub 14. The biasing member 170 is a resilientmaterial, for example a spring material or other elastomeric materialthat may be formed integrally with or connected to the outer sleeve 164.In various exemplary embodiments, the biasing member 170 may be formedas part of, or connected to, the clip 168. A housing 172 surrounds theneedle shield 162. Initially, the opposing member of the inner sleeve166, or clip 168, retains the biasing member 170 in a compressed state.When the inner sleeve 166 is drawn completely into the outer sleeve 164,the biasing member 170 biases the outer sleeve 164, assisting in movingthe catch 174 away from the Luer thread. The features of the exemplaryembodiments of FIGS. 23A and 23B may be combined with features of theother exemplary embodiments disclosed herein as appropriate.

FIGS. 24A-24I depict another exemplary embodiment of an inner sleeve 176having an integral or unitary clip. The inner sleeve 176 and clipcombination may be made from a single piece of metal or plastic, or theymay be made from separate pieces of material that are integrally moldedtogether. The inner sleeve 176 includes an opposing member 180 extendingin a distal direction to enter the catheter hub (not shown) and an outermember 182 extending in a distal direction to enter the outer sleeve(not shown). The outer member 182 has a central cylindrical portion withone or more radially extending ribs. The clip portion of the innersleeve 176 has a first arm 184 and a second arm 186 extending from adistal wall 188. The first and second arms 184, 186 are moveable betweenan open and closed orientation to receive and contain the tip of aneedle (not shown). The features of the exemplary embodiments of FIGS.24A-24I may be combined with features of the other exemplary embodimentsdisclosed herein as appropriate.

Any of the needle shields described above can be used in connection witha multi-use, Luer actuated blood control catheter hub as depicted inFIGS. 25A-26F. The catheter includes a catheter hub 14 and a flexiblecatheter tube extending from the catheter hub. A metal wedge 136 ispositioned in the catheter hub to retain the catheter tube. A septum 138is positioned to control fluid flow through the catheter hub 14. As bestshown in FIG. 25B, the septum 138 has one or more resilient openings orslits 140 designed to selectively prevent unwanted fluid flow throughthe septum 138. The septum 138 has three slits 140 following threetriangular flaps that open when engaged by an actuator 142. The septum138 is made from an elastic material, for example silicone rubber.

The septum 138 further includes a plurality of axial flow channels 139.The flow channels 139 are disposed on an outer circumference of theseptum 138. Eight flow channels 139 equidistant from each other areillustrated, although various quantities and positions are contemplated.The flow channels 139 have an appropriate width and depth so that whenthe septum 138 is not pierced, blood can enter and air can escape thedistal end of the septum 138 in the front portion of the catheter hub.At the same time, the flow channels 139 are sized small enough toprevent the blood from exiting past the septum 138 (at least for someperiod of time). Such a configuration is possible because theintermolecular forces in the blood are greater than the intermolecularthrees in air. The septum 138 shown in FIG. 25B may be used in any ofthe embodiments discussed herein. Other septum configurations may beused as would be understood by one of ordinary skill in the art.

An actuator 142 and a biasing or return member, for example a metal orplastic compression spring 144, are positioned in the catheter hub 14.The actuator 142 engages the septum 138 to open the slits 140 and permitfluid flow through the catheter hub 14. The biasing or return member 144is capable of returning the actuator 142 to a position that allows theresilient slits 140 to close, preventing fluid flow through the catheterhub 14.

The actuator 142 has an actuator barrel 143A surrounding an internalpassage 143B. The actuator barrel 143A is a substantially tubular memberand the internal passage 143B is substantially cylindrical. The tubularmember has one or more openings 143C to permit fluid flow through andaround the actuator barrel. A first end of the actuator barrel has anose with a chamfered outer surface to engage the septum. Afrusto-conical section 145A extends from the second end of the actuatorbarrel 143A. The frusta-conical section 145A has one or more openings145B to permit fluid flow therethrough. A cylindrical section 145Cextends from the frusto-conical section 145A to engage a male Luerconnector. One or more hooks having an angled front surface and a slot147 extend from the actuator barrel 143A.

In the exemplary embodiment shown in FIGS. 25A-26F, the biasing orreturn member is a spring 144, for example a helical compression springwith a distal end and a proximal end. The spring 144 may be made frommetal, plastic, an elastomer, or another suitable resilient material.The distal end of the spring 144 forms an interference fit with theinner surface of the catheter hub 14. The interference fit may besufficient to retain the spring 144, even during loading, or the distalend of the spring 144 may also abut the septum 138. The proximal end ofthe spring 144 connects to the actuator 142, for example by fitting overa hook and into the slot. In other embodiments 142, the actuator 142 andthe biasing member 144 are combined to be a unitary structure. Invarious exemplary embodiments, the inner surface of the catheter hub 14and/or the outer surface of the actuator 142 and/or biasing member 144include undercuts, bumps, projections, tines, or other suitablestructure to form a snap connection between the catheter hub 14 andbetween the biasing member 144, and the biasing member 144 and theactuator 142.

FIGS. 26A-26F depict the operation of the catheter hub 14 with theactuator 142 and biasing member 144. The introducer needle 12 initiallyextends through the actuator 142, the septum 138, the wedge 136, and thecatheter tube 22. After the introducer needle 12 and the catheter tube22 are inserted into a patient, the needle 12 is withdrawn, closing theseptum 138. As the male Luer connector 146 is inserted into the catheterhub 14, the Luer connector 146 abuts and moves the actuator 142 in thedistal direction, compressing the spring 144. Further insertion of theLuer connector 146 moves the actuator 142 through the septum 138,opening the slits 140 and allowing fluid to flow through the catheterhub 14.

When the Luer connector 146 is removed, the spring 144 removes theactuator 142 from the septum 138, closing the slits 140 and preventing,fluid from flowing therethrough. This allows the catheter assembly to bereused through multiple Luer connections, as opposed to a single usecatheter where the actuator 142 would remain in the septum 138 after aLuer connector is removed. However, a single-use catheter without theactuator 142 and/or spring 144 can also be used with the needle shieldsdescribed herein. The features of the exemplary embodiments of FIGS.25A-26F may be combined with features of the other exemplary embodimentsdisclosed herein as appropriate.

FIG. 27 illustrates an exemplary embodiment of an actuator 254. Theactuator 254 can be used in any of the embodiments disclosed herein. Theactuator 254 includes a nose 258 that reduces friction when the actuator254 penetrates into a septum 238 of a catheter hub assembly. Theactuator 254 further includes openings 255 that extend through theactuator 254 in a direction perpendicular to a centerline of theactuator 254. For example, the actuator 254 can include two rectangularshaped openings 255, although more or less are contemplated.

The actuator 254 also includes a plurality of grooves 257 that extendaxially along the distal portion of an outer surface of the actuator 254in a plane parallel to the centerline of the actuator 254. For example,four grooves 257, substantially radially equidistant from each other,can be present along an external surface of the distal portion of theactuator 254, although more or less grooves 257 are contemplated. Thegrooves 257 can be of varying depths into the actuator 254. The grooves257 are different from the openings 255 because the grooves 257 do notextend completely through the thickness of the actuator 254.

The openings 255 and the grooves 257 advantageously provide increasedarea for the fluid to move inside the catheter hub assembly. Theincreased area advantageously allows for fluid flushing and to preventcoagulation of fluid in the proximal and distal ends of the septum.Additionally, the openings 255 and the plurality of grooves 257advantageously minimize the stagnation of fluid and allow for greatermixing. The grooves 257 further prevent the septum from sealing on anoutside surface of the actuator in operation. By not forming a sealinginterface, the fluid is permitted to leak through the septum via thegrooves 57 and provide additional flushing.

FIG. 28A illustrates the actuator 254 of FIG. 27 in the catheter hubassembly. Similar to the embodiments described above, the catheter hubassembly further includes a catheter hub 211, a septum 238 and a biasingmember 256. As illustrated, the openings 255 and the grooves 257 of theactuator 254 provide more area for fluid flow inside the catheter hub214, thus achieving the advantages described above.

FIGS. 28B and 28C illustrate the catheter hub assembly when the biasingmember 256 is compressed and the actuator 254 pierces the septum 238.The catheter hub assembly may be configured such that the openings 255and/or the grooves 257 of the actuator 254 optionally pierce orpenetrate the septum 238. In the embodiment shown, the openings 255 inthe actuator 254 do not penetrate the septum 238. However, the grooves257 in the actuator 254 penetrate the septum 238. This configurationallows for increased fluid flow from the proximal end to the distal endof the septum 38 through the grooves 257, in addition to the advantagesdescribed above. After operation of the catheter assembly is complete,the actuator 254 is retracted from the septum 238 via the force exertedby the biasing member 256. The catheter assembly is configured formultiple uses upon depression of the actuator 254. The featuresdescribed in this embodiment, such as the actuator, can be used incombination with the features described throughout this application.

FIG. 29A illustrates another embodiment of an actuator 364 in a catheterhub assembly. The catheter hub assembly includes a catheter hub 362having a side port 368. The side port 368 provides secondary access tothe fluid flow in the catheter hub 362. The intersection of the mainbore of the catheter hub 362 and the side port 368 includes a sleeve372. The sleeve 372 provides selective fluid communication between theside port 368 and the catheter hub 362. Specifically, when sufficientfluid pressure is applied through the side port 368, the sleeve 372compresses. The compression of the sleeve 372 allows for fluid to enterthe catheter hub 362. Reference is made to U.S. Pat. No. 4,231,367,incorporated by reference herein, for a side port catheter in a catheterassembly of the type described herein. The catheter hub assembly furtherincludes a septum 370 and a biasing member 366 that provides tension tothe actuator 364.

The actuator 364 includes a plurality of openings 365 that extendthrough the actuator 364 in a similar manner as described above. Theactuator 364 includes two rows of four openings 365 having differentsizes and spacing, although various quantities, sizes and spacing of theopenings 365 are contemplated. As illustrated, the openings 365 providemore area for fluid flow inside the catheter hub 362, thus achievingsimilar advantages described above with respect to FIGS. 27-28C.

FIGS. 29B and 29C illustrate the catheter hub assembly when the actuator364 pierces the septum 370 and compresses the biasing member 366. Thecatheter hub assembly is configured such that the openings 365 of theactuator 364 optionally pierce the septum 370. In the embodiment shown,the openings 365 in the actuator 364 do not pierce the septum 370. Thisconfiguration allows for increased fluid flow between the side port 368and the catheter hub 362 at the proximal end of the septum 370, inaddition to the advantages described above. If the openings 365 in theactuator 364 pierce the septum 370, increased mixing of fluid would alsotake place at a distal end of the septum 370.

When operation of the catheter assembly is complete, the actuator 364 isretracted from the septum 370 via the force exerted by the biasingmember 366. The catheter assembly is configured for multiple uses upondepression of the actuator 364. The features described in thisembodiment, including the actuator, can be used in combination with thefeatures described throughout this application.

FIGS. 30-35 describe an alternative embodiment that is similar to theembodiment illustrated in FIGS. 13-16. A catheter hub 400 includes amating member 402 being a protrusion or a thread. The catheter hub 400further incudes an inner diameter 404. As further described in detailbelow, the mating member 402 and the inner diameter 404 are configuredto engage a needle shield assembly 410. The features of the catheter hub400 are similar to that disclosed in the embodiment of FIGS. 13-16.

The needle shield assembly 410 or needle protection device includes aninner member 420, an outer member 430 and a needle hub 450. The innermember 420 includes an opposing member or boss 422, a slot 424 and arecess 426. The opposing member 422 is similar to that disclosed in theembodiment of FIGS. 13-16 and is configured to engage the inner diameter404 of the catheter hub 400.

As illustrated in FIGS. 32-34, the inner member 420 includes the slot424 disposed at a proximal end of the opposing member 422. The slot 424is a recessed cavity that extends through a side portion of the innermember 420 and is configured to advantageously provide a compact spacefor a flexible metal needle shield 460 to be disposed. The slot 424 alsoincludes rounded edges to advantageously provide smooth contact andreduce friction.

FIG. 34 illustrates the recess 426 of the inner member 420. The recess426 is a longitudinal cavity disposed along a top surface of the innermember 420. The recess 426 is configured to engage a protrusion 436 inthe outer member 430. Such engagement advantageously ensures that theinner member 420 moves with respect to the outer member 430 but does notseparate from the outer member 430 after use.

The outer member 430, as illustrated in FIG. 31, includes a catch 432having a mating member 434 such as a thread, and the protrusion 436. Thecatch 432 is disposed over the catheter hub 400. Specifically, themating member 434 of the catch 432 engages the mating member 402 of thecatheter hub 400. The mating members 402, 434 are threads, for example.The catch 432, mating member 434 and protrusion 436 of the outer member430 is similarly disclosed in the embodiment of FIGS. 13-16. Theprotrusion 436 is a flanged-finger like member that flexes and isconfigured to engage or lock into the recess 426 and operate in themanner described above.

As illustrated in FIG. 30, the needle hub 450 encloses the inner andouter member 420, 430. Specifically, the needle hub 450 covers the catch432 engaging the catheter hub 400. Such a configuration preventsaccidental tampering with the engagement of the mating members 434, 402.The needle hub 450 is similarly disclosed in the embodiment illustratedin FIGS. 13-16.

The flexible needle shield 460 is made of a thin spring metal,preferably a stainless steel, although other flexible materials arecontemplated. The flexible needle shield 460 is configured to shield aneedle 470 in the inner member 420. The flexible needle shield 460includes an opening or aperture 462 and a distal surface 464. Theopening 462 is a hole in the flexible needle shield 460 that allows theneedle 470 to pass through in a first (extended) position of the needle470. The distal surface 464 of the flexible needle shield 460 isdisposed between a proximal surface of the catheter hub 400 and a distalsurface of the outer member 430 in the first (extended) position of theneedle 470. When the flexible needle shield 460 is disposed in the first(extended) position, it is in its tensioned state.

When the needle 470 is retracted to a second (retracted) position, thedistal surface 464 of the flexible needle shield 460 is released.Subsequently, the flexible needle shield 460 returns to its natural orrelaxed state to shield or block the distal tip of the needle 470 viathe distal surface 464. That is, the opening 462 is no longer alignedwith the direction of movement of the needle 470. Instead, the distalsurface 464 blocks the needle 470 in its direction of movement. Themovement of the flexible needle shield 460 causes the distal tip of theneedle 470 to be shielded or blocked.

The needle 470 further includes a needle bump or deformation 472. Thedeformation 472 contacts a washer 480 when the needle 470 is retractedto the second (retracted) position. A hole in the washer 480 blocks thedeformation 472 from passing through. As a result, the washer 480 andthe inner member 420 move in the proximal direction to shield the needle470 in the second (retracted) position. Alternately, the washer 480 canbe incorporated into the distal end of the flexible needle shield 460.The needle 470, deformation 472 and washer 480 are similarly disclosedin the embodiment illustrated in FIGS. 13-16. The operation of theneedle shield assembly 410 is described in further detail below.

FIG. 30 illustrates the needle 470 in the first (extended) position. Inthis position, the assembly is ready for needle insertion into a vein ofa patient.

FIG. 31 illustrates how the needle shield assembly 410 is coupled to thecatheter hub 400. The interlocking of the mating members 402, 434operate in a similar manner to the embodiment illustrated in FIGS.13-16. Specifically, the inner and outer members 420, 430 cooperatetogether to capture the threads in the mating member 402 of the catheterhub 400. Additionally, the opposing member 422 engages the innerdiameter 404 of the catheter hub 400.

FIG. 32 illustrates the flexible needle shield 460. A proximal portionof the flexible needle shield 460 is fixed to a proximal surface of thewasher 480. The flexible needle shield 460 bends approximately 90° andis disposed along a bottom surface of the inner member 420. The flexibleneedle shield 460 near its distal is bent in a curvilinear fashion andis disposed into the slot 424 of the inner member 420. Accordingly, thedistal surface 464 of the flexible needle shield 460 is disposed andheld between the proximal surface of the catheter hub 400 and the distalsurface of the outer member 430 in the first (extended) position of theneedle 470.

The flexible needle shield 460 engages the slot 424 to restrict themovement of the inner member 420. Specifically, the inner member 420remains engaged to the catheter hub 400 via the opposing member 422.

FIG. 33 illustrates the needle shield assembly 410 with the needle 470in the second (retracted) position. In this position, the outer member430 begins to disengage from the catheter hub 400. The needle 470 isalso withdrawn from the catheter hub 400 and the distal tip of theneedle 470 passes the slot 424 of the inner member 420. Before passingthe slot 424 of the inner member 420, the drag force between the needle470 and the flexible needle shield 460 is minimal because the distalsurface 464 is held by the catheter hub 400 and the outer member 430.

After passing the slot 424 during needle retraction, frictional forcesarise between the needle 470 and the flexible needle shield 460.However, the total frictional force is significantly lower than thatdisclosed in the embodiment of FIGS. 13-16.

When the catheter hub 400 and the outer member 430 are disengaged, thedistal surface 464 of the flexible needle shield 460 is released andsprings downward to its natural state to cover the inner hole of theinner member 420. As a result, the aperture 462 no longer lines up withthe inner hole of the inner member 420. The needle 470 can no longertravel through the aperture 462 of the flexible needle shield 460.Instead, the distal tip of the flexible needle shield 460 is shielded orblocked by the distal surface 464 of the flexible needle shield 460.

As the user continues to withdraw the needle 470, the inner member 420moves proximally via the contact between the needle deformation 472 andthe washer 480. Specifically, the washer 480 prevents the needledeformation 472 from exiting. As a result, the needle 470 moves thewasher 480 and the washer 480 contacts the inner member 420 to move inthe proximal direction. This functionality is similarly disclosed in theembodiment illustrated in FIGS. 13-16.

This movement causes the opposing member 422 to disengage the catheterhub 400 as illustrated in FIG. 34. Subsequently, the outer member 430can be lifted upward and disengaged from the catheter hub 400. Asillustrated in FIG. 35, the catheter hub 400 and the needle shieldassembly 410 are separated. This disengagement is similarly disclosed inthe embodiment illustrated in FIGS. 13-16.

Although the needle shield assembly 410 is disengaged from the catheterhub 400, as illustrated in FIG. 34, the inner and outer members 420, 430are engaged via the recess 426 in the inner member 420 and theprotrusion 436 in the outer member 430. This configurationadvantageously prevents separation of the inner and outer members 420,430.

The foregoing detailed description of the certain exemplary embodimentshas been provided for the purpose of explaining the principles of theinvention and its practical application, thereby enabling others skilledin the art to understand the invention for various embodiments and withvarious modifications as are suited to the particular use contemplated.This description is not necessarily intended to be exhaustive or tolimit the invention to the precise embodiments disclosed. Any of theembodiments and/or elements disclosed herein may be combined with oneanother to form various additional embodiments not specificallydisclosed. Accordingly, additional embodiments are possible and areintended to be encompassed within this specification and the scope ofthe invention. The specification describes specific examples toaccomplish a more general goal that may be accomplished in another way.

As used in this application, the terms “front,” “rear,” “upper,”“lower,” “upwardly,” “downwardly,” and other orientational descriptorsare intended to facilitate the description of the exemplary embodimentsof the present invention, and are not intended to limit the structure ofthe exemplary embodiments of the present invention to any particularposition or orientation. Terms of degree, such as “substantially” or“approximately” are understood by those of ordinary skill to refer toreasonable ranges outside of the given value, for example, generaltolerances associated with manufacturing, assembly, and use of thedescribed embodiments.

The invention claimed is:
 1. A catheter assembly comprising: a flexiblecatheter; a needle having a sharp distal tip, wherein the needle isconfigured to be disposed in the flexible catheter and configured tomove from a first position that exposes the sharp distal tip of theneedle to a second position; an outer member that is configured toengage and disengage a catheter hub; an inner member movably disposed inthe outer member; and a needle shield for shielding at least a distalend of the needle when the needle is in the second position, the needlepassing through the needle shield in the first position, and the needleshield being disengaged from the catheter hub in the first position;wherein the needle shield comprises a flexible strip having a proximalend, a distal end and an aperture formed in a wall of the flexible stripthat allows the needle to pass through the aperture in the firstposition; and in the second position, the aperture is misalignedrelative to the distal end of the needle thereby enclosing the distalend of the needle by the distal end of the flexible strip to shield theneedle.
 2. The catheter assembly according to claim 1, wherein the outermember engages with the catheter hub when the needle is in the firstposition.
 3. The catheter assembly according to claim 1, wherein a catchin the outer member engages with a protrusion in the catheter hub. 4.The catheter assembly according to claim 1, wherein the inner member isconfigured to axially move relative to the outer member when the needleis in the second position.
 5. The catheter assembly according to claim1, wherein the inner member includes a slot; and the needle shield isdisposed in the slot.
 6. The catheter assembly according to claim 1,wherein the inner member includes a recess; the outer member includes aprotrusion; and the protrusion engages the recess to ensure that theinner member is disposed within the outer member.
 7. The catheterassembly according to claim 1, wherein the needle shield engages a slotin the inner member to restrict movement of the inner member when theneedle is in the first position.
 8. The catheter assembly according toclaim 1, wherein the needle shield is made of a thin spring metal. 9.The catheter assembly according to claim 1, wherein a distal surface ofthe needle shield is secured between the catheter hub and the outermember when the needle is in the first position.
 10. The catheterassembly according to claim 1, wherein a distal surface of the needleshield shields the sharp distal tip of the needle when the needle is inthe second position.
 11. The catheter assembly according to claim 1,wherein a distal surface of the needle shield is disengaged from thecatheter hub and the outer member when the needle is in the secondposition.
 12. The catheter assembly according to claim 1, wherein theinner member has an opposing member; and the opposing member is disposedin the catheter hub when the needle is in the first position.
 13. Thecatheter assembly according to claim 12, wherein when the opposingmember is disposed in the catheter hub, the outer member engages thecatheter hub.
 14. The catheter assembly according to claim 1, wherein:the needle further includes a deformation; and the deformation isconfigured to be enclosed by the needle shield when the needle is in thesecond position.
 15. The catheter assembly according to claim 14,wherein the deformation of the needle is configured to cause the innermember to axially move relative to the outer member.
 16. A method ofoperating a catheter assembly comprising: disposing a needle having asharp distal tip in a flexible catheter and moving the needle from afirst position where the sharp distal tip of the needle is exposed, to asecond position, a needle shield being disengaged from a catheter hubwhen the needle is in the first position; retracting the needle from thecatheter hub, through the flexible catheter and through an apertureformed in a wall of a flexible strip of the needle shield; shielding atleast the sharp distal tip of the needle by a distal end of the needleshield and in an inner member when the needle is in the second position;the inner member movably disposed in an outer member; the outer memberconfigured to engage and disengage the catheter hub; and moving theneedle shield and the outer member when retracting the needle to thesecond position to misalign the aperture relative to the sharp distaltip of the needle.
 17. The method according to claim 16, furthercomprising: securing a distal surface of the needle shield between thecatheter hub and the outer member into an open position when the needleis in the first position.
 18. The method according to claim 16, furthercomprising: disengaging a distal surface of the needle shield betweenthe catheter hub and the outer member into a closed position when theneedle is in the second position.